Liquid transfer device with dual lumen iv spike

ABSTRACT

A liquid transfer device includes a monolithic trifurcated connector body defining a barrel at a first end thereof, a single IV spike at a second end thereof and a vial adapter lumen at a third end thereof. An IV port is connected to the barrel. The single IV spike has a first IV spike lumen fluidly connected at a proximal end thereof with only the vial adapter lumen via the trifurcated connector body and a second IV spike lumen fluidly connected at a proximal end thereof with only the IV port via the trifurcated connector body, thereby separating fluid communication between the vial adapter and the single IV spike from fluid communication between the IV port and the single IV spike.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority and benefit from U.S. ProvisionalPatent Application No. 62/840,620, titled “Liquid Transfer Device WithDual Lumen IV Spike”, filed on Apr. 30, 2019, the entire contents ofwhich are incorporated by reference herein.

BACKGROUND OF THE DISCLOSURE

The present disclosure is generally directed to liquid transfer devices.

Conventional infusion liquid containers containing an infusion liquid tobe delivered to a patient generally take the form of an infusion liquidbag, an infusion liquid bottle, and the like. A pre-filled syringe orvial is generally utilized to add a high concentration of a drug to theinfusion liquid contents, via a liquid transfer device, to form adiluted, medicated infusion liquid. Thereafter, an infusion setincluding an IV spike may be inserted into an IV port of the liquidtransfer device for infusion of medicated infusion liquid contents to apatient. Minimizing the risk of a patient receiving a portion of thedrug in a highly concentrated, undiluted form is important for patientsafety.

BRIEF SUMMARY OF THE DISCLOSURE

The present disclosure realizes the advantageous manufacture of a liquidtransfer device having separate lumens: one for mixing the highconcentration of drug with the infusion liquid, and one for transferringthe diluted, medicated infusion liquid to the infusion set, as an addedmeasure to prevent the patient from receiving a portion of the drug inan undiluted, high concentration form. The present disclosureadditionally or alternatively realizes the advantageous manufacture of aliquid transfer device capable of mixing the fluid within the lumenbetween the IV port and the port connected to the medicated infusionliquid contents prior to administering the medicated infusion liquidcontents to a patient.

Briefly stated, one aspect of the present disclosure is directed to aliquid transfer device configured for use with each of an infusionliquid container containing an infusion liquid and having an intravenous(IV) port for administering the infusion liquid, a vial containing amedicament additive sealed by a vial stopper, and an infusion setincluding an IV spike for sealing insertion into an IV port and aconnector, such as an infusion set, for administration purposes to apatient. The liquid transfer device includes a monolithic trifurcatedconnector body defining a barrel at a first end thereof, a single IVspike at a second end thereof and a vial adapter lumen at a third endthereof. An IV port is connected to the barrel and configured tosealingly receive the IV spike of the infusion set. A vial adapter ispermanently secured to the vial adapter lumen and configured totelescopically mount onto the vial. The vial adapter includes a vialspike fluidly connected with the vial adapter lumen and configured topuncture the vial stopper upon mounting of the vial adapter onto thevial for flow communication therewith. The single IV spike is configuredto sealingly insert into the IV port of the infusion liquid container.The single IV spike has a first IV spike lumen fluidly connected at aproximal end thereof with only the vial adapter lumen via thetrifurcated connector body and a second IV spike lumen fluidly connectedat a proximal end thereof with only the IV port via the trifurcatedconnector body, thereby separating fluid communication between the vialadapter and the single IV spike from fluid communication between the IVport and the single IV spike while enabling initial introduction of themedicament additive from the vial to the infusion liquid containerthrough the vial adapter and the first IV spike lumen for mixing withthe infusion liquid to form a medicated infusion liquid, and enablingsubsequent administration of the medicated infusion liquid to a patientfrom the infusion liquid container through the second IV spike lumen andthe IV port to the infusion set. The first IV spike lumen has a firstperipherally disposed distal aperture and the second IV spike lumen hasa second peripherally disposed distal aperture.

Briefly stated, another aspect of the present disclosure is directed toa method of using a liquid transfer device having a monolithictrifurcated connector body defining a barrel at a first end thereof, asingle intravenous (IV) spike at a second end thereof and a vial adapterlumen at a third end thereof. The method includes the steps of mountinga vial adapter permanently secured to the vial adapter lumen onto a vialcontaining a medicament additive, and, in turn, piercing a stopper ofthe vial with a vial spike of the vial adapter fluidly connected withthe vial adapter lumen; piercing an IV port of an infusion liquidcontainer containing an infusion liquid with the single IV spike; andadding the medicament additive within the vial to the infusion liquidwithin the infusion liquid container (i.e. mixing the medicament withthe infusion liquid) to obtain a medicated infusion liquid via the vialadapter lumen and a first IV spike lumen of the single IV spike. Thefirst IV spike lumen is fluidly connected at a proximal end thereof withonly the vial adapter lumen via the trifurcated connector body and has afirst peripherally disposed distal aperture proximate a distal end ofthe single IV spike. The method also includes the step of inserting anIV spike of an infusion set into an IV port of the liquid transferdevice, the IV port of the liquid transfer device being fluidlyconnected to a second IV spike lumen of the single IV spike. The secondIV spike lumen is fluidly connected at a proximal end thereof with onlythe IV port and has a second peripherally disposed distal apertureproximate the distal end of the single IV spike, thereby fluidlyconnecting the infusion set with the infusion liquid container foradministration of the medicated infusion liquid to a patient.

BRIEF DESCRIPTION OF THE DRAWINGS

The following detailed description of aspects of the disclosure will bebetter understood when read in conjunction with the appended drawings.It should be understood, however, that the disclosure is not limited tothe precise arrangements and instrumentalities shown. In the drawings:

FIG. 1A is a front elevational view of an infusion liquid container inthe form of a bag usable with a liquid transfer device according to thepresent disclosure;

FIG. 1B is a front elevational view of an infusion liquid container inthe form of a flexible bottle usable with a liquid transfer deviceaccording to the present disclosure;

FIG. 1C is a front elevational view of a pre-filled needleless syringeand a vial usable with the liquid transfer device according to thepresent disclosure;

FIG. 1D is a front elevational view of an infusion set usable with theliquid transfer device according to the present disclosure;

FIG. 2A is a perspective view of the liquid transfer device, inaccordance with a first embodiment of the present disclosure, in adepressed plunger configuration;

FIG. 2B is a cross-sectional elevational view of the liquid transferdevice of FIG. 2A, taken along sectional line 2B-2B of FIG. 2A;

FIG. 3 is a perspective view of the syringe plunger and an IV port ofthe liquid transfer device of FIG. 2A;

FIG. 4A is a perspective view of the liquid transfer device according tothe present disclosure, in a withdrawn plunger configuration;

FIG. 4B is a cross-sectional elevational view of the liquid transferdevice of FIG. 4A, taken along sectional line 4B-4B of FIG. 4A;

FIG. 5 is a cross-sectional elevational view of another embodiment of aliquid transfer device having an alternatively configured IV spike;

FIG. 6 is a cross-sectional elevational view of the liquid transferdevice of FIG. 2A, taken along sectional line 2B-2B of FIG. 2A, havinganother alternatively configured IV spike;

FIG. 7A is an enlarged cross-sectional elevational view of oneconfiguration of a vial adapter of the liquid transfer device of FIG.2A;

FIG. 7B is an enlarged cross-sectional elevational view of anotherconfiguration of a vial adapter of the liquid transfer device of FIG.2A;

FIG. 8 is a perspective view of a liquid transfer device, in accordancewith a second embodiment of the present disclosure;

FIG. 9 is a cross-sectional elevational view of the liquid transferdevice of FIG. 8, taken along sectional line 9-9 of FIG. 8; and

FIG. 10 is an enlarged partial, exploded, perspective view of analternative attachment between a trifurcated connector body and anelongate connecting member, such as an IV port, of the liquid transferdevice of FIG. 8.

FIGS. 11A and 11B are cross-sectional elevational views of anotherembodiment of the liquid transfer device of FIG. 6 having an internalvalve.

DETAILED DESCRIPTION OF THE DISCLOSURE

Certain terminology is used in the following description for convenienceonly and is not limiting. The words “lower,” “bottom,” “upper” and “top”designate directions in the drawings to which reference is made. Thewords “inwardly,” “outwardly,” “upwardly” and “downwardly” refer todirections toward and away from, respectively, the geometric center ofthe liquid transfer device, and designated parts thereof, in accordancewith the present disclosure. Unless specifically set forth herein, theterms “a,” “an” and “the” are not limited to one element, but insteadshould be read as meaning “at least one.” The terminology includes thewords noted above, derivatives thereof and words of similar import.

It should also be understood that the terms “about,” “approximately,”“generally,” “substantially” and like terms, used herein when referringto a dimension or characteristic of a component of the disclosure,indicate that the described dimension/characteristic is not a strictboundary or parameter and does not exclude minor variations therefromthat are functionally similar. At a minimum, such references thatinclude a numerical parameter would include variations that, usingmathematical and industrial principles accepted in the art (e.g.,rounding, measurement or other systematic errors, manufacturingtolerances, etc.), would not vary the least significant digit.

Referring to the drawings in detail, wherein like numerals indicate likeelements throughout, there is shown in FIGS. 2A-6 a liquid transferdevice 30, in accordance with a first embodiment of the presentdisclosure, intended for use with the combination of infusion liquidcontainers containing an infusion liquid and additive transfer devices.In the illustrated embodiment, the liquid transfer device 30 is intendedfor use with an infusion liquid container in the form of an infusionliquid bag 10 (FIG. 1A). As should be understood by those of ordinaryskill in the art, a conventional infusion liquid bag 10 includes areservoir 12 containing infusion liquid, in fluid communication with anintravenous administration port 14 and an additive port 16. The infusionliquid bag 10 is collapsible upon administration of the infusion liquidtherefrom. The liquid transfer device 30 may also be used with aninfusion liquid container in the form of a flexible infusion liquidbottle 18 (FIG. 1B) or the like. The liquid transfer device 30 of theillustrated embodiment is also intended for use with an additivetransfer device in the form of a sealed vial 20 (FIG. 1C). The vial 20generally contains a highly concentrated medicament liquid additive or alyophilized powder drug requiring reconstitution prior to administrationto a patient, i.e., requiring mixing with the infusion liquid in the bag10 to form a medicated infusion liquid administered to a patient. Thecontents of the vial 20 are, therefore, introduced into the infusionliquid bag 10 via the liquid transfer device 30 (as will be described infurther detail below). The liquid transfer device 30 may also, however,take a different configuration intended for use with a syringe 22 (FIG.1C) containing a medicament liquid additive.

The liquid transfer device 30 includes a trifurcated connector body 32.In the illustrated embodiment of FIGS. 2A-6, the trifurcated connectorbody 32 is a monolithic body defining a barrel 34 at a first endthereof, a single IV spike 36 at a second end thereof, and a vialadapter 38 at a third end thereof, but the disclosure is not so limited(as described further below). As shown best in FIGS. 2B, 4B and 5, thebarrel 34 defines an internal chamber 34 a having an open proximal end34 b for slidably receiving a plunger 40 (as will be described furtherbelow). The IV spike 36 defining the second end of the trifurcated body32 enables use of the liquid transfer device 30 with infusion liquidbags 10, i.e., for sealingly inserting the IV spike 36 into theadministration port 14 of the bag 10. The IV spike 36 may be constructedfrom a suitable rigid metal, polymeric or plastic material, such as, forexample, polycarbonate and the like. A flange 33 extends laterally fromthe IV spike 36 proximate a proximal end thereof to provide a grippingor bearing surface to enable a user to more easily insert the IV spike36 into a liquid container, such as bag 10. The IV spike may optionallyinclude a feature, such as raised step 35 around the circumferentialsurface of the IV spike 36, for restricting insertion depth into theadministration port 14 of the bag 10. In one embodiment, the flange 33may also be formed as an injection molded monolithic structure with theconnector body 32, but the disclosure is not so limited. A spike cap(not shown) may removably cover the IV spike 36 when not in use.

As shown, the IV spike 36 is co-directional and/or coaxial with thebarrel 34 and includes two internal lumens 36 a, 36 b. In theillustrated configurations, the lumens 36 a, 36 b extend generallyparallel to one another. The first IV spike lumen 36 a is continuouslyand directly fluidly connected at a proximal end with only a vialadapter lumen 37 located within the vial adapter 38 angularlybifurcating from, i.e., branching off of, the IV spike 36. The first IVspike lumen 36 a includes a first peripherally disposed distal aperture36 c. As shown best in FIGS. 2B, 4B and 5, the first IV spike lumen 36 ais not fluidly connected at the proximal end thereof with the barrelchamber 34 a. The second IV spike lumen 36 b is directly fluidlyconnectable at a proximal end with only the barrel chamber 34 a andincludes a second peripherally disposed distal aperture 36 d, separatefrom the first distal aperture 36 c of the first IV spike lumen 36 a.The second IV spike lumen 36 b is not fluidly connected at the proximalend thereof with the vial adapter lumen 37 or at any point along thelength of the IV spike 36. In other words, IV spike 36 includes twoseparate lumens 36 a, 36 b that extend through the IV spike 36 toprovide discrete fluid paths that are not connected within the IV spike36. Thus, fluid communication between the vial adapter 38 and the IVspike 36 is separate from fluid communication between the barrel chamber34 a and the IV spike 36.

The vial adapter 38 is configured to mount onto a vial 20 to enableusage of the device 30 with an additive transfer device in the form of avial 20. In one configuration, the vial adapter 38 may be integrallyformed at the third end of the connector body 32, i.e., monolithicallyformed with the terminal end of the vial adapter lumen 37 or otherwisepermanently secured and sealed to the terminal end of the vial adapterlumen 37, but the disclosure is not so limited. As used herein throughthe specification and the claims, “permanently secured” means notdisconnectable/removable without causing damage to the device or portionthereof. As one non-limiting example, the vial adapter 38 may beultrasonically welded to the vial adapter lumen 37.

Referring to FIG. 7A, the vial adapter 38 includes a top wall 38 d, aflexible and/or flared skirt 38 a depending therefrom for telescopicsnap fit mounting onto a vial 20 (in a standard manner) and a vial spike38 b for puncturing the vial 20, e.g., through a stopper thereof, tofluidly communicate with the interior of the vial 20. The puncturingvial spike 38 b includes a lumen 38 c in fluid communication with thevial adapter lumen 37, and, in turn with the first IV spike lumen 36 a.As should be understood by those of ordinary skill in the art, the innerdiameter of the vial spike 38 b, i.e., the diameter of the lumen 38 c,and/or the outer diameter of the vial spike 38 b may be dimensioned asappropriate for the intended use.

In the configuration of FIG. 7A, the vial spike 38 b includes a basesection 39 that is generally concave with respect to the axis of thevial spike 38 b. The vial adapter 38 may alternatively be configured tominimize/protect against leakage resulting from the tear that forms inthe stopper of a vial 20 as the vial adapter 38 is pushed down onto thevial 20 and the vial spike 38 b advances through the stopper. Asillustrated in the configuration of FIG. 7B, the direction of extensionof the base section 39′ is generally convex with respect to the axis ofthe vial spike 38 b such that the base section 39′ has a generallybulbous configuration. When the vial adapter 38 is pushed down onto thevial 20 and the spike 38 b advances through the vial stopper, the basesection 39′ is compressed against an upper surface of the vial stopperand the compressed material of the vial stopper surrounds tears formedin the vial stopper for sealing thereof. Puncturing of the vial stopperby the vial spike 38 b is generally accompanied by the formation of adepression in the upper surface of the vial stopper. The convex basesection 39′ is configured to fill in the depression, therebyminimizing/protecting against leakage. As should be understood by thoseof ordinary skill in the art, however, different sealing basesections/means, currently known, or that later become known, may beemployed to minimize leakage between the vial spike 38 b and the elasticstopper of vial 20. As also should be understood, other vial adapterconfigurations, currently known, or that later become known, mayalternatively be employed.

Turning to the plunger 40, as shown best in FIGS. 2B, 3, 4B and 5, theplunger 40 includes an upright plunger tube 46, defining a plunger tubelumen 46 a therein. The plunger tube 46 is slidably engaged with thebarrel 34 via a peripheral sealing member 42 (constructed, for example,of an elastomeric material or the like) interposed therebetween in amanner well understood by those of ordinary skill in the art, permittingsliding within the barrel 34 while creating a substantially air-tightseal between the plunger tube 46 and the interior sidewall of the barrel34. The plunger tube 46 and the sealing member 42, in combination withthe barrel 34, define a sealed proximal end of the barrel chamber 34 a.The plunger tube 46 includes a distal, elongate neck portion 44terminating in a check valve 48. In the illustrated embodiment, thecheck valve 48 takes the form of a duckbill valve, constructed of anelastomeric material or the like, but the disclosure is not so limited.For example, without limitation, the check valve 48 may take the form ofseveral other types of one-way valves, such as, for example, a ballvalve, a silicone flapper valve, a diaphragm-type valve, an in-linevalve, a stop-check valve, a lift-check valve, or the like, capable ofperforming the functions of the check valve 48 described herein.

As shown, an IV port 50 is fluidly connected with a proximal end of theplunger tube 46. The IV port 50 includes a twist-off member 50 aproximate a peripheral, free proximal end of the port 50, and anelongate connecting member 52 projecting distally therefrom, having aninternal lumen 52 a extending therethrough and terminating in an openend (opposite end from the twist-off member 50 a). The internal lumen 52a of the IV port 50 extends co-directionally and/or coaxially with theplunger lumen 46 a. In one embodiment, the IV port 50 may be constructedfrom a suitable flexible polymeric or plastic material, such as, forexample, PVC, and the like. In the illustrated embodiment, the elongateconnecting member 52 is adhered, i.e., adhesively bonded, with theplunger tube 46, but the disclosure is not so limited. For example,without limitation, the elongate connecting member 52 may be permanentlysecured and rotationally fixedly attached to the plunger tube 46 (forexample, as described in further detail below with respect to FIGS. 8 to10).

The IV port 50 includes a septum 50 b positioned within the elongateconnecting member 52, sealing across the internal lumen 52 a.Accordingly, the twist-off member 50 a may be removed without leading toflow communication beyond the septum 50 b. Flow communication beyond theseptum 50 b, i.e., with the plunger lumen 46 a and beyond, is onlyachieved upon puncturing the septum 50 b (as described in further detailbelow). The twist off member 50 a keeps the IV port 50, and particularlythe septum 50 b, sterile until use.

In use, the liquid transfer device 30 may be coupled to an infusionliquid bag 10 via the IV spike 36 (as previously described). Thereafter,the user withdraws the plunger 40 in a proximal direction, i.e. in adirection away from the IV spike 36 (FIGS. 4A, 4B). Alternatively, adedicated handle may be employed and attached to the plunger 40 fortranslation thereof. Withdrawal of the plunger 40, with the distalaperture 36 d immersed in the infusion liquid within the bag 10, pullsfluid from the bag 10, through the distal aperture 36 d, through thesecond IV spike lumen 36 b and into the barrel chamber 34 a. Theduckbill valve 48 is configured to prevent fluid flow into the plungertube lumen 46 a during plunger 40 withdrawal. As should be understood bythose of ordinary skill in the art, withdrawal of the plunger 40 createsa vacuum in the barrel chamber 34 a, resulting in a pressure differencerelative to the infusion liquid bag 10, thereby pulling the fluid intothe barrel chamber 34 a. As also should be understood, the infusionliquid remains within the barrel chamber 34 a and the second IV spikelumen 36 b until manually ejected, in a manner well understood by thoseof ordinary skill in the art, as will be described below.

Prior or subsequent to withdrawing infusion liquid from the infusionliquid bag 10 into the barrel chamber 34 a, the liquid transfer device30 may be coupled to a vial 20 via the vial adapter 38 (as previouslydescribed). A user may mix/combine the contents within the vial 20 withthe contents within the infusion liquid bag 10 via the vial adapterlumen 37 and the first IV spike lumen 36 a by inverting the infusionliquid bag 10 and device 30, i.e. positioning the vial 20 above the bag10, so that the contents of the vial 20 drain into the infusion liquidbag 10. Where the vial 20 contains a lyophilized powder drug, the drugcan be reconstituted in a similar fashion. After coupling the vial 20 tothe liquid transfer device 30, the liquid bag 10 is held above the vial20, so that liquid from the liquid bag 10 drains into the vial 20 andreconstitutes the contents of the vial 20. The infusion liquid bag 10and device 30 may then be inverted, as previously described, to drainthe reconstituted contents of the vial 20 into the bag 10.

After mixing/combining the contents within the infusion liquid bag 10and the vial 20 and orienting the liquid transfer device 30 such thatthe combined liquid flows into the infusion liquid bag 10, the plunger40 is depressed until at least portion of the duckbill valve 48 engagesthe proximal end/rim of the second IV spike lumen 36 b. In theillustrated embodiment, at least one of the elastomeric lips/flaps ofthe duckbill valve 48 abuts, and is displaced/compressed by, theproximal end 41 of the second IV spike lumen 36 b, thereby opening theduckbill valve 48 for fluid-flow therethrough. That is, sustainedpressure applied onto at least one of the elastomeric lips/flaps of theduckbill valve 48, resulting from the depression of the plunger 40 to aposition engaging the valve 48 with the proximal end/rim 41 of thesecond IV spike lumen 36 b, displaces the elastomeric lips/flaps of thevalve 48 from one another, thereby breaking the seal therebetween andpermitting fluid flow therethrough. Thereafter, the twist-off member 50a is removed (in a manner well understood) to provide access to theinternal lumen 52 a. An IV port spike 96 of an infusion set 95 (FIG. 1D)is sealingly inserted into the internal lumen 52 a and fully penetratesthe septum 50 b, thereby fluidly connecting the IV port spike 96 withany remainder of the internal lumen 52 a beyond the septum 50 b, and, inturn, with the plunger lumen 46 a and the second IV spike lumen 36 b(via the open duckbill valve 48) for administration of the medicatedinfusion liquid to a patient. The IV port spike 96 typically extendsfrom an end of a drip chamber 97 a of the infusion set 95.Conventionally, an infusion set 95 additionally includes a roller clamp97 c for controlling fluid administration to a patient, a male Luerconnector 97 d, and tubing 97 b to fluidly connect the roller clamp 97 cto the drip chamber 97 a.

Advantageously, the medicated infusion liquid is fluidly connected tothe infusion set 95 via the second IV spike lumen 36 b rather than thefirst IV spike lumen 36 a, which is utilized only to admix the highlyconcentrated drug additive within the vial 20 with the infusion liquidwithin the bag 10. Thus, the possibility of administering a portion ofthe drug additive in an undiluted, high concentration form to a patientis minimized. Moreover, as the plunger 40 is depressed (as previouslydescribed), infusion liquid within the barrel chamber 34 a is ejectedthrough the second IV spike lumen 36 b and out the distal aperture 36 d.Therefore, after utilizing the liquid transfer device 30 to admix thecontents within the infusion liquid bag 10 and the vial 20, the secondIV spike lumen 36 b and the distal aperture 36 d thereof, though notutilized for mixing, are nevertheless flushed out prior to use thereoffor transferring the medicated infusion liquid from the bag 10 to theinfusion set 95, to further minimize the possibility of administering aportion of the drug additive in an undiluted, high concentration form toa patient.

In an alternative configuration, as shown in FIG. 5, a distal end of theIV spike 36′ is configured such that the first IV spike lumen 36 a′extends further distally than the second IV spike lumen 36 b′.Advantageously, therefore, the first distal aperture 36 c′ is separatedby a distance “d” from the distal aperture 36 d′, thereby furtherminimizing the opportunity for a portion of the drug in an undiluted,high concentration form from exiting the first distal aperture 36 c′ andentering the distal aperture 36 d′. The distance “d” is preferablygreater than or equal to about 1.0 mm, more preferably greater than orequal to about 2.5 mm, and most preferably greater than or equal toabout 4.0 mm.

In another alternative configuration, as shown in FIG. 6, the IV spike36″ may include a single lumen 36 a″ with a single distal aperture 36c″. This configuration operates in a similar manner as with theconfiguration shown in FIGS. 2-4B, except that withdrawing/ejectingfluid from or into the barrel chamber 34 a and mixing the drug withfluid occurs in part through a common portion of the single lumen 36 a″.Flushing of the lumen 36 a″, as previously described, is performedbetween the steps of mixing/combining the contents within the infusionliquid bag 10 and the vial 20, and removing the twist-off member 50 afor connection of the infusion set 95.

In a preferred embodiment illustrated in FIGS. 11A and 11B, a flowcontrol valve 43 may be incorporated in the device, such that rotationof the flow control valve 43 allows a user to selectively fluidlyconnect either the vial adapter lumen 37 or the barrel chamber 34 a withthe single lumen 36 a″. The valve 43 may prevent any highly concentrateddrug additive within the vial 20 from being drawn into the barrelchamber 34 a when the plunger tube 46 is withdrawn, as illustrated inFIG. 11A. Prior to mixing the contents of the vial 20 into the bag 10,the valve 43 may be rotated in order to provide a fluid connectionbetween the vial adapter lumen 37 and the single lumen 36 a″, as well asseal off the barrel chamber 34 a, as illustrated in FIG. 11B. In orderto flush the volume of liquid within the single lumen 36 a″, the valve43 may be rotated back to its original position in FIG. 11A prior todepressing the plunger tube 46.

In another alternative embodiment, the vial adapter 38 may bedetachable. For example, the device may be provided with a valve, suchas the needleless additive control valve disclosed in U.S. Pat. No.8,551,067, the contents of which are incorporated by reference herein.The valve would allow the vial adapter 38 to be detached prior towithdrawing the plunger tube 46. The vial adapter 38 and vial 20 wouldthen be connected via the valve to empty the highly concentratedcontents of the vial 20 into the bag 20 followed by depression of theplunger tube 46 to flush the single lumen 36 a″.

FIGS. 8-10 illustrate a second embodiment of the liquid transfer device130. The reference numerals of the second embodiment are distinguishablefrom those of the above-described first embodiment configurations (FIGS.2A-7B) by a factor of one-hundred (100), but otherwise indicate the sameelements as indicated above, except as otherwise specified. The liquidtransfer device 130 of the present embodiment is similar to that of thefirst embodiment configurations. Therefore, the description of certainsimilarities and modes of operation between the embodiments may beomitted herein for the sake of brevity and convenience, and, therefore,is not limiting.

One difference of the liquid transfer device 130 over the liquidtransfer device 30 pertains to the configuration of the first end ofconnector body 132. As shown in FIGS. 8 and 9, the plunger 40 is removedand the IV port 150 is directly and permanently secured and sealed tothe barrel 134, i.e., not disconnectable/removable without causingdamage to at least one of the IV port 150 or the barrel 134 or otherwiseto the device 130. Accordingly, the second IV spike lumen 136 b of thesingle IV spike 136 is in direct and continuous fluid communication at aproximal end with only the internal lumen 152 a of the elongateconnecting member 152 of the IV port 150, while remaining not fluidlyconnected at the proximal end thereof with the vial adapter lumen 137.The first IV spike lumen 136 a of the single IV spike 136 also remainscontinuously and directly fluidly connected at a proximal end with onlythe vial adapter lumen 137 and not fluidly connected at the proximal endthereof with the internal lumen 152 a of the elongate connecting member152.

In the illustrated embodiment of FIGS. 8 and 9, the elongate connectingmember 152 is adhered, i.e., adhesively bonded, with the barrel 134. Aspreviously noted, the elongate connecting member 152 may be permanentlysecured attached to the barrel 134. For example, as shown in FIG. 10,the barrel 134 may terminate in a barbed fitting member 154 having anopen end 154 a. The barbed fitting member 154 may be configured, i.e.,size, dimension, material, relative to the internal diameter andmaterial of the elongate connecting member 152 to advance into theinternal lumen 152 a and form a barbed, friction, i.e., interference,fit therebetween. As should be understood by those of ordinary skill inthe art, the orientation of the barbed fitting member 154 permitsadvancement thereof into the internal lumen 152 a to sealingly andsecurely mount the IV port 150 co-directionally upon the barrel 134 ofthe connector body 132, and also substantially prevent withdrawal of thebarbed fitting member 154 without damaging at least one of the elongateconnecting member 152 and the barbed fitting member 154.

As shown, the barbed fitting member 154 is frustoconically shaped,having a progressively increasing diameter in a direction away from theopen end 154 a. An opposing end of the barbed fitting member 154 definesa greater diameter from the underlying portion of the barrel 134,resulting in an annular rib 156 that provides an interference fit withthe interior sidewall of the elongate connecting member 152, uponattempted withdrawal of the barbed fitting member 154 out of theelongate connecting member 152. Accordingly, the barbed fitting member154 is advanceable into the internal lumen 152 a of the elongateconnecting member 152 during assembly, and, thereafter, is not readilyable to be withdrawn without causing damage.

Additionally, the rim of the elongate connecting member 152 defining anopen end 152 b thereof includes at least one cutout 158 a, and thebarrel 134 includes a corresponding at least one radial tab 158 bprotruding from the barrel 134 and configured to mate with the at leastone cutout 158 a. In the illustrated embodiment, the elongate connectingmember 152 includes a plurality of angularly spaced cutouts 158 a, andthe barrel 134 includes a corresponding plurality of angularly spacedtabs 158 b. The tab(s) 158 b mates with the cutout(s) 158 a duringmounting of the IV port 150 upon the barbed fitting member 154 of thebarrel 134, to rotationally fix the IV port 150 relative to theremainder of the liquid transfer device 130. The tab(s) 158 b alsoprevent relative rotation between the barrel 134 and the elongateconnecting member 152 and enable a twist-off member 150 a to be removed,as noted below, prior to connection to the infusion set 95.

In use, the liquid transfer device 130 may be coupled to a vial 20 viathe vial adapter 138 and the user may mix/combine the contents withinthe vial 20 with the contents within the infusion liquid bag 10, via thevial adapter lumen 137 and the first IV spike lumen 136 a. Aftermixing/combining the contents within the infusion liquid bag 10 and thevial 20 and orienting the liquid transfer device 130 such that thecombined liquid flows into the infusion liquid bag 10, the twist-offmember 150 a is removed (in a manner well understood) to provide accessto the internal lumen 152 a and the IV port spike 96 of an infusion set95 (FIG. 1D) is sealingly inserted into the internal lumen 152 a andfully penetrates the septum 150 b, thereby fluidly connecting the IVport spike 96 with any remainder of the internal lumen 152 a beyond theseptum 150 b, and, in turn, with the second IV spike lumen 136 b foradministration of the medicated infusion liquid to a patient.

It will be appreciated by those skilled in the art that changes could bemade to the embodiments described above without departing from the broadinventive concepts thereof. For example instead of a vial adapter, thetrifurcated connector body 32, 134 may include a normally closed (NC)needleless additive port (not shown) at the third end thereof (enablingselection of use with a syringe 22 or with a vial 20). As anotherexample, the vial adapter 38, 138 can be replaced by a manually operatedstop cock, and the like. As yet another example, the liquid transferdevice 30 may include a locking mechanism to stabilize and/or lock theplunger 40 in the different positions thereof. It is understood,therefore, that this invention is not limited to the particularembodiments disclosed, but it is intended to cover modifications withinthe spirit and scope of the present disclosure, as set forth in theappended claims.

1. A liquid transfer device configured for use with each of an infusionliquid container containing an infusion liquid and having an intravenousadministration port for administering the infusion liquid, a vialcontaining a medicament additive sealed by a vial stopper, and aninfusion set including an IV port spike and a connector foradministration purposes to a patient, the liquid transfer devicecomprising: a monolithic trifurcated connector body defining a barrel ata first end thereof, a single IV spike at a second end thereof and avial adapter lumen at a third end thereof; an IV port connected to thebarrel and configured to sealingly receive the IV port spike of theinfusion set; a vial adapter comprising the vial adapter lumen andconfigured to telescopically mount onto the vial, the vial adapterincluding a vial spike fluidly connected with the vial adapter lumen andconfigured to puncture the vial stopper upon mounting of the vialadapter onto the vial for flow communication therewith, and the singleIV spike being configured to sealingly insert into the intravenousadministration port of the infusion liquid container, and the single IVspike having: a first IV spike lumen fluidly connected at a proximal endthereof with only the vial adapter lumen via the trifurcated connectorbody, the first IV spike lumen having a first peripherally disposeddistal aperture; and a second IV spike lumen fluidly connected at aproximal end thereof with only the IV port via the trifurcated connectorbody, the second IV spike lumen having a second peripherally disposeddistal aperture; thereby separating fluid communication between the vialadapter and the single IV spike from fluid communication between the IVport and the single IV spike while enabling initial introduction of themedicament additive from the vial to the infusion liquid containerthrough the vial adapter and the first IV spike lumen for mixing withthe infusion liquid to form a medicated infusion liquid, and enablingsubsequent administration of the medicated infusion liquid to a patientfrom the infusion liquid container through the second IV spike lumen andthe IV port to the infusion set.
 2. The liquid transfer device of claim1, wherein the first IV spike lumen is directly and continuously fluidlyconnected with only the vial adapter lumen.
 3. The liquid transferdevice of claim 2, wherein the second IV spike lumen is directly andcontinuously fluidly connected with only the IV port.
 4. The liquidtransfer device of claim 1 wherein the IV port is permanently secured tothe barrel.
 5. The liquid transfer device of claim 1 wherein the firstIV spike lumen extends further distally than the second IV spike lumen,whereby the first peripherally disposed distal aperture is distallyspaced from the second peripherally disposed distal aperture along thesingle IV spike.
 6. The liquid transfer device of claim 1 furthercomprising a plunger including a plunger tube defining a plunger tubelumen therein, wherein the barrel defines an internal chamber fluidlyconnected with the second IV spike lumen and sealingly and slidablyreceiving the plunger tube.
 7. The liquid transfer device of claim 6,wherein the plunger tube is fluidly connected with the IV port via aproximal end thereof and the plunger tube includes a check valve at adistal end thereof, whereby the IV port is fluidly connected with thesecond IV spike lumen in an open position of the check valve and fluidlydisconnected from the second IV spike lumen in a closed position of thecheck valve.
 8. The liquid transfer device of claim 6 wherein the firstIV spike lumen and the second IV spike lumen extend parallel to oneanother.
 9. A method of using a liquid transfer device having amonolithic trifurcated connector body defining a barrel at a first endthereof, a single intravenous (IV) spike at a second end thereof and avial adapter lumen at a third end thereof, the method comprising:mounting a vial adapter comprising the vial adapter lumen onto a vialcontaining a medicament additive, and, in turn, piercing a stopper ofthe vial with a vial spike of the vial adapter fluidly connected withthe vial adapter lumen; piercing an administration port of an infusionliquid container containing an infusion liquid with the single IV spike;adding the medicament additive within the vial to the infusion liquidwithin the infusion liquid container to obtain a medicated infusionliquid via the vial adapter lumen and a first IV spike lumen of thesingle IV spike, the first IV spike lumen being fluidly connected at aproximal end thereof with only the vial adapter lumen via thetrifurcated connector body and having a first peripherally disposeddistal aperture proximate a distal end of the single IV spike; insertingan IV port spike of an infusion set into an IV port of the liquidtransfer device, the IV port of the liquid transfer device being fluidlyconnected to a second IV spike lumen of the single IV spike, wherein thesecond IV spike lumen is fluidly connected at a proximal end thereofwith only the IV port and having a second peripherally disposed distalaperture proximate the distal end of the single IV spike, therebyfluidly connecting the infusion set with the infusion liquid containerfor administration of the medicated infusion liquid to a patient. 10.The method of claim 9, wherein the first IV spike lumen extends furtherdistally than the second IV spike lumen, whereby the first peripherallydisposed distal aperture is distally spaced from the second peripherallydisposed distal aperture along the single IV spike.
 11. A liquidtransfer device configured for use with each of an infusion liquidcontainer containing an infusion liquid and having an intravenousadministration port for administering the infusion liquid, a vialcontaining a medicament additive sealed by a vial stopper, and aninfusion set including an IV port spike and a connector foradministration purposes to a patient, the liquid transfer devicecomprising: a monolithic trifurcated connector body defining a barrel ata first end thereof, a single IV spike at a second end thereof and avial adapter lumen at a third end thereof; an IV port connected to thebarrel and configured to sealingly receive the IV port spike of theinfusion set; a vial adapter comprising the vial adapter lumen andconfigured to telescopically mount onto the vial, the vial adapterincluding a vial spike fluidly connected with the vial adapter lumen andconfigured to puncture the vial stopper upon mounting of the vialadapter onto the vial for flow communication therewith, the single IVspike comprising an IV spike lumen and being configured to sealinglyinsert into the intravenous administration port of the infusion liquidcontainer, and a plunger including a plunger tube defining a plungertube lumen therein, wherein the barrel defines an internal chamberfluidly connected with the IV spike lumen and sealingly and slidablyreceiving the plunger tube, wherein plunger tube is fluidly connectedwith the IV port via a proximal end thereof and the plunger tubeincludes a check valve at a distal end thereof, whereby the IV port isfluidly connected with the second IV spike lumen in an open position ofthe check valve and fluidly disconnected from the second IV spike lumenin a closed position of the check valve.
 12. The liquid transfer deviceof claim 11, further comprising a flow control valve configured toselectively fluidly connect the IV spike lumen to the vial adapter lumenor the barrel.
 13. The liquid transfer device of claim 11, wherein thevial adapter is detachable.